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SIGA Technologies Inc. (NASDAQ: SIGA) is a commercial-stage pharmaceutical company that targets the health security market. SIGA specializes in the development of antiviral therapeutics aimed at treating some of the world's most lethal pathogens including smallpox, Ebola, dengue, and Lassa fever. The company's flagship product, TPOXX® (also known as tecovirimat and ST-246®), is an oral and intravenous formulation antiviral drug approved for the treatment of human smallpox disease caused by the variola virus.
TPOXX has received approval from multiple regulatory bodies. In 2018, the U.S. Food and Drug Administration (FDA) approved the oral formulation of TPOXX, followed by approval for the intravenous formulation in 2022. The European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom also approved oral TPOXX in 2022 for treating smallpox, monkeypox, cowpox, and complications arising from vaccinia virus infections post smallpox vaccination.
In recent developments, SIGA has expanded its reach in Europe through a joint procurement mechanism, allowing multiple EU countries to access oral TPOXX. Orders under this mechanism are anticipated to generate around $164 million in 2023, with a substantial portion of deliveries expected within the year. As such, the company projects a pre-tax operating income between $90 million and $100 million for 2023. Additionally, SIGA has recently amended its international promotion agreement with Meridian Medical Technologies, Inc., granting SIGA primary responsibility for promoting oral TPOXX in various territories, including the European Union, thereby enhancing its global reach.
SIGA also maintains a strong relationship with the Biomedical Advanced Research and Development Authority (BARDA) for the procurement and development of both oral and intravenous formulations of TPOXX under Project BioShield. This partnership underscores SIGA's commitment to enhancing global health security through its innovative antiviral treatments.
With a clear focus on health security, SIGA aims to address high-priority biological threats, providing solutions that are crucial in preparing for and mitigating the impact of infectious diseases and potential bioterrorist threats.
SIGA Technologies, a pharmaceutical company focused on health security, announced that CEO Dr. Phillip L. Gomez will participate in a fireside chat at the Cantor Fitzgerald Virtual Global Healthcare Conference on September 17, 2020, at 8:00 a.m. ET. The event will be accessible via a live webcast on the company's website, with a replay available afterward. SIGA’s primary product is TPOXX® (tecovirimat), an antiviral approved for smallpox treatment. The U.S. maintains a stockpile of 1.7 million doses under Project BioShield.
In Q2 2020, SIGA Technologies reported total revenues of $40.3 million, a significant increase from $28.8 million in Q2 2019. Operating income improved to $3.9 million compared to a loss of $1.7 million a year earlier. The company successfully delivered 117,000 courses of TPOXX to the Strategic National Stockpile, generating $36.2 million in revenue. SIGA also expanded its international presence with a delivery of 2,500 courses to Canada. The company filed a Marketing Authorisation Application for oral tecovirimat, targeting approval in H2 2021.
SIGA Technologies, Inc. (SIGA) will host a webcast and conference call on August 6, 2020, at 4:30 P.M. ET to discuss a business update. Dr. Phil Gomez, CEO, and Daniel Luckshire, CFO, will participate. The call will be available on the company's website or by telephone. A replay will be provided for two weeks. SIGA focuses on health security, with TPOXX® as their lead product, approved for smallpox treatment. The company signed a contract with BARDA worth $51.6M for additional TPOXX development.
SIGA Technologies has filed a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for oral tecovirimat, previously approved as TPOXX by the FDA. This filing seeks a broader indication to treat smallpox, monkeypox, cowpox, and Vaccinia complications, targeting approval in the second half of 2021. SIGA aims to enhance access to this essential antiviral across Europe, following its collaborative development with the U.S. Government. The U.S. maintains a stockpile of 1.7 million doses of TPOXX to mitigate bioterror threats.
SIGA Technologies (NASDAQ: SIGA) announced the delivery of oral TPOXX® (tecovirimat) to the U.S. Department of Health and Human Services (HHS), valued at approximately $32 million. This delivery marks the initial phase of a contract option worth $101.3 million under the 2018 BARDA Contract. The contract has up to $414 million remaining for future procurement. Dr. Phil Gomez emphasized the importance of preparing for potential biological threats during the ongoing COVID-19 pandemic.
SIGA Technologies, Inc. (SIGA) has received an increase in funding of approximately $23 million from the United States Department of Defense (DoD) to support research for expanding the FDA label of its antiviral drug TPOXX (tecovirimat) for Post-Exposure Prophylaxis (PEP) against smallpox. This potential label expansion is crucial in the event of a smallpox outbreak, as vaccines alone have limitations in effectiveness. TPOXX may be administered over 28 days for PEP, contrasting with the 14-day treatment for active infections. The company aims to enhance early treatment options for individuals at risk.
On June 1, 2020, SIGA Technologies, Inc. (SIGA) announced that its 2020 Annual Meeting of Stockholders will be held virtually on June 16, 2020, at 10:30 a.m. Eastern Time, due to COVID-19 safety concerns. Stockholders as of April 24, 2020, can attend the meeting via a live audio webcast. They must submit their votes in advance, as voting during the meeting will not be permitted. SIGA focuses on health security and is known for TPOXX, a treatment for smallpox. A notice regarding the virtual format has been filed with the SEC.
SIGA Technologies announced the delivery of 2,500 courses of TPOXX® (tecovirimat) to the Canadian Department of National Defence as part of an agreement for up to 15,325 courses valued at $14.3 million. Deliveries are expected to continue pending regulatory approval by Health Canada. Additionally, SIGA plans to deliver $101.3 million of TPOXX to the U.S. Government related to a BARDA contract. The contract could yield up to $414 million in future purchases, underscoring SIGA's role in biodefense and health security.
SIGA Technologies, Inc. (SIGA) reported a Q1 2020 revenue of approximately $2.6 million, resulting in an operating loss of about $4.0 million and a loss per diluted share of $0.11. The company exercised contract options totaling $101.3 million from BARDA for oral TPOXX® deliveries expected by April 2021. SIGA also maintains a strong cash position of $77.4 million. Despite concerns over the COVID-19 pandemic, the company does not anticipate a material adverse effect on its financial condition or annual results.
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